Speech Generating Devices

There are three fundamental points with regard to Medicare coverage of SGDs we bring to your attention:

1. Every American has a right to enjoy the freedoms of life, liberty and the pursuit of happiness, a constitutional affirmation reinforced by the Americans with Disabilities Act. To limit disabled persons’ access to communication on the basis that non-disabled persons could use the same devices or software is a denial of that right. Concerns about unintended or fraudulent use of covered devices or software can be addressed by measures other than throwing the baby out with the bath water.

2. The Affordable Care Act provides that patients must communicate with their physicians via a portal, which is always internet-based. Furthermore, State laws governing professional practice and conduct by licensees in the health professions also require them to communicate with their patients, including those with communication disorders. Such a requirement becomes critical in the case of licensees in the mental health professions whose primary therapy is verbal communication. Therefore, CMS guidelines shouldn’t disallow internet connectivity from SGDs as it may controvert law.

3. Life evolves over time as does technology, an increasingly pervasive part of modern life. Since the technology supporting SGDs has advanced substantially over the past decade, the guidelines for addressing that technology should reflect, not restrict, that evolution.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking); Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair. Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help Allowing users to control access to the home, for example to allow access to the home for emergency responders These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories. Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6. The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone. Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options. Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.

Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries. For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

All people should have the method of communication available to them that is appropriate for them. All people also should have the right and ability to choose their method of communication for each specific situation. The representatives for the people who can easily access their own methods of communication need to ensure that the people they are representing have the ability and option to choose their method of communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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To Whom it May Concern:

I request that you QUICKLY approve the proposed restoration the scope of SGD coverage that had existed from 2001-2013, both in regard to the types of devices that can be used as SGDs – both computers and purpose built devices; and in regard to the capabilities or features of SGDs.

Also, please support funding of eye-tracking access AND repeal of the capped rental regulation that could put some people at risk of losing their system if they had extended hospitalization.

Thank you,
Jennifer Abramson

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enable remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please remove the capped rule on SGDs to allow our patients to communicate.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);

Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and

Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help

Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.

Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.

Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.

Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.

Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please don't take away the only voice many of my clients have! This funding source is needed. Without it, many of them could not afford a communication device.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

To anyone who has ever had a loved one to lose their voice is understanding how important SGD' s are to living a quality life. I ask that you accept the proposed changes recommended by ASHA. Sincerely, Rebecca Adams

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Speech generating devises make a major difference in a person's whole life. Let's not make people who need them do without these essential devises. Let's allow them to change as the person's ability communicate changes too. These devises are the person's whole way of interacting with the world. Without them, they are voiceless & powerless.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Sincerely,
Rhoda Agin, Ph.D.

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A group that included policy experts from ASHA, the Amyotrophic Lateral Sclerosis Association (ALSA,) and representatives from SGD manufacturers has discussed and agreed on edits to the NCD 50.1 to submit to CMS as a united stakeholder group. The recommended edits are the result of several meetings, revisions, and discussions and include:

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On behalf of the Institute on Disabilities at Temple University, we thank you for this opportunity to comment on Medicare's (CMS) reconsideration of its National Coverage Decision (NCD) for Speech Generating Devices (SGDs). For more than 40 years, the Institute on Disabilities at Temple University has served as Pennsylvania’s University Center for Excellence in Developmental Disabilities (UCEDD) Education, Research, and Service, established under the federal Developmental Disabilities Assistance and Bill of Rights Act. The Institute also serves as Pennsylvania's Assistive Technology Act program established under the Federal Assistive Technology Act. As the Commonwealth's UCEDD and AT Act program, we interact with tens of thousands of people with disabilities every year, many of whom use or need SGDs. In addition, we provide communication assessments for adults with intellectual and developmental disabilities (ID/DD), following protocols established as a result of the 2001 NCD on SGDs, and have seen the way SGDs provide people with ID/DD a way to control their health – and their world.

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including:

- Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
- Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
- Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

- Providing users the ability to access medical alerting systems to call for help
- Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

- Enabling users to be left alone
- Enabling independent access to care at home
- Providing the ability to maintain family and parental roles
- Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

- The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
- Managing communication about health care appointments and transportation to health care appointments
- Enabling users to receive information about disasters and emergency actions
- Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

- Calling for help in an emergency using a text-to-911 or instant message relay service
- Enabling users to receive and respond to safety and emergency alerts
- Sending an instant message to a caregiver in another room to request assistance
- Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
- Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
- Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
- Accessing online user guides and technical support for training or troubleshooting with the SGD
- Enabling remote technical support, trouble shooting and device repair.
- Downloading page sets for use with the SGD’s communication software
- Keeping in touch with family and friends who live far away or are otherwise unable to visit
- Participating in online support groups

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

- Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
- Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

- Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
- Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
- Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
- Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries. For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

Thank you for you consideration of these comments. If you have any questions or would like further information, please contact Amy Goldman at amy.Goldman@temple.edu or 215-204-1356.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

It is my hope that this correspondence will enhance your understanding of what speech generating devices are AND what they can mean in the lives of so many around us. We have the power and the resources to give a voice to the subaltern, to enhance the quality of life for those otherwise unable to communicate with loved-ones and strangers alike, and to facilitate language-based communication (rather than needs-based communication). There is no good reason to limit or restrict anyone's RIGHT to communicate 1) exactly what they want to say, 2) as efficiently as possible.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please do not limit the types of devices available to Medicare beneficiaries, or their ability to functionally communicate with others. Thank you.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As an AAC specialist, I provide people without speech a “voice.” Communication is imperative to social and medical well-being. I want to thank Medicare for addressing key concerns which were in the 2014 proposed Medicare National Coverage determination for Speech Generating Devices. Most of us use electronic devices to communicate via text such as text messages and e-mail and most people have access to a phone. Allowing people with speech disabilities to access the same means of communication is imperative for their ability to function as close to their peers as possible. These days, doctors’ offices text appointment reminders, physician’s communicate with patients using e-mail, and many employers only offer applications via e-mail or online. It is essential that the revised NCD for SGDs be signed as soon as possible to expand “speech” to include these means of communicating as an option that can be made available. The sooner this is adopted, the sooner people with a need will have access and confusion over the matter will be eliminated. It is also of extreme importance that eye tracking accessories be addressed in NCD for SGDs as this is the only means of access some people with disabilities would have to independent message composition. The issue of capped rentals is also in need of resolution. One specific point is that “Standard” devices rented would only include the ability for face-to-face communication and would not allow for access for other communicative options such as phone use, texting, and e-mail—as noted previously these are imperative for functioning in today’s society. With the capped rental policy as is, these would be unavailable and would be an issue. I also asked that there be further clarification between “functional speaking needs” and “functional speaking communication needs.” In the field of speech-language pathology, we utilize the term “functional communication needs” as there is far more to communication than speaking. Congruence of terms is crucial in eliminating confusion and misunderstanding. Please consider these imperative points for the NCD for SGDs. Again, thank you for revising some of the key issues. I hope that the remaining concerns of the AAC community can be resolved as well.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Support access to the SGD for patients with neurodegenerative diseases. Don't prevent it's important use for patients. Do what is necessary to allow for accessibility.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please make these changes as soon as possible. There are patients with progressive diseases like ALS that are being severely affected by these rules. To think that someone that is having all of their human abilities taken away slowly be given a device that can improve their quality of life. But then that new device is either limited via the inability to use email etc or taken away completely via the capped rental system if they have to receive hospice care or go in skilled nursing is just illogical and inhumane! Nobody would think it reasonable if it happened to one of their own family members!

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech-language pathologist for over 10 years, I have worked with many individuals who use SGDs.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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December 6, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

These patients and students have the right to communicate in the way that best suits their needs.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please allow those in need the eligibility to obtain an SGD covered through medicare. SGD's are essential and paramount for the communication of those who cannot speak verbally or are limited verbally. SGD's allow social abilities, communication of wants/needs, and for the utmost dignity in life. Please advocate and allow SGD's as a covered service to medicare beneficiaries.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge you to keep coverage of eye tracking accessories for speech generating devices.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

As a speech pathologist, I have trained patients to use this technology when they have no other volitional movements to access their communication devices. Taking away coverage for this technology takes away one's ability to communicate needs, wants, thoughts, and even goodbyes to loved ones.

Thank you for your reconsideration to the coverage policy.

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[PHI Redacted] has this device and it is the only voice my kids know from him. If he didn't have it the would not be able to get to know the man i know. He would be a memory before he even is dead. It has also been the only way he can communicate his needs. Without the device [PHI Redacted] has to say each letter of the alphabet and wait till [PHI Redacted] blinks to acknowledge the letter he is thinkibg. Imagine doing that for 30 minutes just to get a simple sentence spoken. ALS has taken away pretty much everything [PHI Redacted] use to be able to do. This device gives him back one of the most important things he lost. His ability to communicate with family and friends. Without it he would be a sitting duck. It is his only interaction with the world.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Thank you for time and understanding.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Sincerely,
Janice Andersen

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I have worked as a speech language pathologist in a medical setting for 36 years with consumers who have lost their ability to talk. Only paper and pencil or cardboard pages were used as compensations for loss of speech. Through the years, technology has exploded to restore talking skills for these consumers through the invention & evolution of Speech Generating Devices (SGD). SGD’s are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.  

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs.  The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.  

Some of these device features are not within the client’s control, and none add costs to Medicare.  The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients. 

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders These capabilities also promote independent living by:
• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. 

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD.  From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered. 

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.  These choices must be maintained. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency.   This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate.  To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have witnessed first hand how important these devices can be to help students connect socially with others and convey messages more effectively.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Please continue funding speech generated devices:

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs). SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electonic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities which do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. The availability of this feature results in no additional cost to CMS. Instead, the ability of an SGD to perform environmental control functions requires substantial additional expense – in the form of home and appliance modifications – by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enable remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access thier SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.

These choices must be maintained. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.

Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

For children with severe communication deficits, to deny them access to basic ability to communicate effectively is truly punitive beyond the burden they already are subjected. Would you deny this to Stephen Hawkings; one of the greatest minds of our times? Would you deny your child, your parent or sibling the ability to tell someone they are sick, sad, hurt or want to share a joke? Please, do not disallow the very basic needs of communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enable remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Dear Dr. Duggirala,

Please consider and include the revisions and recommendations submitted by ASHA concerning "speech-generating devices." These devices empower our most vulnerable citizens to communicate their basic needs and to engage with others whereas in the past these individuals were relegated to silence.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Good morning. I am writing this comment to you on the internet, participating in a public policy discussion over medical issues based on communications I received through social media from individuals involved with caring for ALS sufferers. They've let me know that your recent policy changes with regard to speech generating & communication technology would take away the ability of individuals in advanced stages of ALS to communicate in the way I am communicating right now, as well as with their family members, doctors, and to generally interact with the world around them.

ALS, and other terrible medical conditions that rob people of the ability to communicate, are devastating enough. But if the technology exists that can lessen the impact and allow these individuals to continue to interact with the world around them, I feel that should continue to be supported and expanded, not taken away or limited. I hope you will address this in your policies going forward.

Thank you for taking the time to read this public comment.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs). I am currently a Masters student in Speech-Language Pathology at Boston University and will be graduating in May 2015. I hope to work with individuals with complex communication needs, such as those who may require the use of SGDs as their primary mode of communication, and I find the potential for future lack of coverage troubling.

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking); Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair. Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help Allowing users to control access to the home, for example to allow access to the home for emergency responders These capabilities also promote independent living by:

Enabling users to be left alone Enabling independent access to care at home Providing the ability to maintain family and parental roles Enabling the ability to pursue volunteer or community activities The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster Managing communication about health care appointments and transportation to health care appointments Enabling users to receive information about disasters and emergency actions Enabling users to receive and respond to safety and emergency alerts The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service Enabling users to receive and respond to safety and emergency alerts Sending an instant message to a caregiver in another room to request assistance Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals Participating in tele-health visits with healthcare providers when travel to a clinic is impossible Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics Accessing online user guides and technical support for training or troubleshooting with the SGD Enabling remote technical support, trouble shooting and device repair. Downloading page sets for use with the SGD’s communication software Keeping in touch with family and friends who live far away or are otherwise unable to visit Participating in online support groups or patient communities such as PatientsLikeMe One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories. Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6. The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone. Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options. Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.

Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries. For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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I have met a person who uses eye-gaze technology as his only means of communication and I have spoken with several people who support others who are in the same position.

Such speech-generating devices, and the ability to use such devices through the Internet, are essential to such persons' standard of living and essential for that person health.

They are essential for communicating with health professionals and essential for informing others about their symptoms and health needs.

Also, the use of both such devices and the Internet together is specifically necessary for those who have rare conditions such as ALS to discover, contact, and interact with ALS support groups and other individuals living with ALS about matters essential to their health, about the unique health-related choices with which they are faced, and about options they might not otherwise learn about directly from their specific health care providers.

Finally, the destructive force of rare conditions such as ALS, which cause the deficiencies speech generating devices are meant to alleviate, includes the harsh psychological trauma which results from forced solitude and an oftentimes bleak terminal diagnosis; empowering those who suffer from such diseases to communicate with the world outside their rooms' - both about themselves, about their conditions, and about their thoughts as well as about the world outside - is one of the surest and best means to counteract that trauma.

I urge you to consider carefully and compassionately the comments that are made in favor of permitting such Internet-accessible speech generating devices to those suffering from diseases like ALS and I urge you conclude this period of review in their favor.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease that took my sister's life. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

Thank you!

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enable remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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The use of communication technology is becoming more and more intimate with all members of society. Nowhere is this more evident than within communities of individuals who use this technology to share and connect with the rest of the world. The devices human beings use to communicate, when other avenues are lost, must have the ability to be tailored to their specific needs.

The terms of the capped rental category put the individual at risk of losing his or her method of communication at the most crucial and vulnerable of times – extended hospital stays, assisted living facilities, hospice care. Medicare provided SGDs need to be owned by the recipient in order for the devices to be customized so they are a valid and USABLE method of communication, adapted to the unique needs of the individual, and protected to insure the device can not be taken away when needed most.

I work for people who live with ALS. This disease takes away a tremendous amount from a person – a family – a community. However – it does not take away the person’s right to participate in decisions that directly affect his or her life. Devices with the ability to be unlocked allow a person living with ALS to remain in control of medical decisions, appointment scheduling and cancelling, and participating in telemedicine if and when travel to medical appointments becomes impossible.

It is crucial that people with disabilities severe enough to require these devices have access to assistance – from notifying a person within the same house but outside the immediate room that help is needed up to being able to connect with 911 services. Dialing 9-1-1 is the most familiar and effective way Americans have of finding help in an emergency. The Americans with Disabilities Act (ADA) requires all Public Safety Answering Points (PSAPs) to provide direct, equal access to their services for people with disabilities who use alternative methods of communications. Under Title II Emergency centers have to be able to get calls from TDD/TTY and computer modem users without relying on third parties or state relay services. As technological capabilities continue to expand to improve quality of life, so must our access laws.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please accept the proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD. Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare. The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Communication is imperative to the health and quality of life of every person in any form.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as "dedicated speech devices." As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client's control, and none add costs to Medicare.

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "wireless" capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the "coverage reminder" was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as "environmental control" or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients. Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "environmental control" capability as disqualifying for Medicare coverage and payment. Although the "coverage reminder" was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "cellular communication" capability as disqualifying for Medicare coverage and payment. Although (1) "phone control" is not "cellular communication" capability, (2) SGDs typically do not include "cellular communication" capability, and (3) the "coverage reminder" was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 - 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device's role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked. Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD's communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS "codes" that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person's communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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There are many ugly diseases out there but 1 main one that has affected both [PHI Redacted] is ALS. Their ONLY form of communication was through the devices that help them to communicate. It should be a vital part of their life and "necessary" so they can maintain communication with their family members not only as a means of telling them their wishes or thoughts, but telling them necessary vital information about thier physical needs as well. It's their only form of communication when nothing else is functioning body wise. It should definitely covered as is any other medical necessity is to their disease. Thank you.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

The ability to verbally communicateis a basic human need. Speech- Generating devices will allow persons with limited ability to verbally communicate to indicate their wants and needs.

Persons who have a problem verbally communicating are frustrated because they are unable to say what is on their minds. This also affects family members and friends who find it difficult to communicate with them as they are often forced to quess what their loved one needs.

Speech-Generating devices will also allow some persons with limited ability to verbally communicate to continue working.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.
In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage. The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.   
Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs.  The 2001 NCD did not restrict any of these operational characteristics of SGDs, including Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.  
Some of these device features are not within the client’s control, and none add costs to Medicare. 
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.
SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients. 
Environmental control capabilities provide important benefits to clients. They aid safety by:
Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:
Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.
A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. 
Examples of why phone control is essential include:
The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.
Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD.  From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.
Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.
Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:
Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.
Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered. 
Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.
The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.
Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:
In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.  These choices must be maintained.
For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency.   This option also is cost-efficient for Medicare. However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained. Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate.  To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

The ability to communicate one's basic wants and needs is a fundamental human right. With the advanced capabilities of technology these days, we need to take advantage of what is available to help everyone exercise this right to communicate. I've personally seen how these devices help those with communication impairments escape the personal prison of isolation that neurodegenerative diseases trap them in. A device with the ability to access people outside of the immediate environment (via internet capability for Skype or email transcription or telephone use) helps people stay healthier and happier. Being able to communicate their wants and needs with caregivers and medical professionals helps them stay ahead of the disease process and reduce risks of frequent re hospitalizations. Please please please accept these revisions to stay on the front line of communication access for Medicare recipients.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please allow people with catastrophic illnesses to communicate through the use of speech generating devices.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I have been working in the field of augmentative and alternative communication for more than thirty years. When I heard about Capped Rental, I suspected that it was likely to have significant impact on the field. When I learned some of the details, I was confused, surprised, and then worried. I am going to discuss only one of its provisions: the withdrawal of equipment during hospital or rehabilitation center stays.

Communication disabilities, in many ways, are like sensory impairments. The person with communication disabilities may have difficulties talking, making telephone calls, buying things at stores, banking, writing messages, etc. A person with sensory impairments (vision and hearing) has trouble talking, using phones, buying things, banking, etc. The two sets of disabilities are in certain ways parallel.

Suppose CMS regulations would require that eye glasses and hearing aids be returned to their manufacturer when their users went in for a hospital stay. The general public would be able to see immediately how strange such a requirement would be.

It is as though, when entering a hospital, a person would need to send back to a manufacturer his or her eye glasses and hearing aids.

A communication aid is personal and non-generic as hearing aids and eye glasses. Having to send it back when going to the hospital or rehab center makes as much sense as sending back prescription glasses and hearing aids.

How many Medicare users would like to relinquish their eye glasses and hearing aids for a hospital stay? The absurdity of this situation is an exact parallel with relinquishing one's speech-generating device (SGD).

I hope I have made myself clear

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December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I work with students with severe autism and these devices are helping so many children communicate their wants, needs, thoughts, and feelings. They are a vital tool for so many and they need to be funded.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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ALS patients cannot communicate except with their eyes after not that long. When this happens, studies show that they often enter a downward spiral that leads to death fairly soon. I mean, how would you handle it if you had a perfectly good mind trapped inside a failing body that could not communicate with the outside world?

This dilemma is inevitable, however. ALS patients can still use their eyes for a long time after they can't use their voice or control a keyboard or joystick. However, in order to utilize this, they need a computer (tablet most likely) to do eye tracking.

This computer needs to be part of what Medicare gives someone with ALS. Further, almost anyone today uses the internet to communicate with, via email and social media and the like. Ergo, Medicare really needs to cover internet access for ALS patients.

In case you want to see some more street creds from this commentator, check out teamgleason.eecs.wsu.edu.

THINK ABOUT THIS ..... and then do the right thing!!!!

Dave

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PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.h
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.

Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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[PHI Redacted] passed away from ALS in September of 2012, and speech generating devices are imperative for communication between the patient and their caregivers. Imagine yourself being locked into your body, but your mind fully active and you need to tell someone that you need your arm moved because it is throbbing in pain and you cannot communicate your need. No one would ever know if these patients need medical attention without this device. Please, please, please give people with these needs this device. It helps to alleviate suffering for all involved in the care of patients. Thank you for putting patients' care first and foremost. Sincerely, Pam Balch

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The current situation, created by CMS in the Spring of 2014, is causing real and serious harm to Medicare beneficiaries with severe communication disabilities. The combination of changing to the 13 month rental system adding to the pressure on SGD vendors (resulting from the coverage "reminder") has led to a situation where beneficiaries have been renting speech-only devices that cannot be upgraded. Clear and poignant evidence of the harmful effect that CMS is currently causing on beneficiaries can be seen in the following videos:

http://www.bostonherald.com/news_opinion/local_coverage/2014/09/medicare_shushes_als_sufferers

http://fox6now.com/2014/07/02/not-having-these-locks-you-away-from-the-world-how-you-can-help-als-patients-get-the-speech-generating-devices-they-need/

http://www.frequency.com/video/speech-generating-device-helps-als/192853792?cid=5-5338

2. SGD manufacturers will continue to proceed with extreme caution regarding upgrades until CMS publishes a new national coverage decision. CMS is directly responsible for this, because of clear pressure on the manufacturers to conform to the so-called "coverage reminder," as is evidenced by the statement from a prominent member of the Chronic Care Policy Group at the Centers for Medicare & Medicaid Services: "I thought the SGD “coverage reminder” issue was on its way to resolution and that manufacturers pledged to come into compliance. I’m wondering why ITEM coalition was hired to approach CMS on something that 90 percent of the manufacturers understood they needed to address and were in the process of doing so?”

3. Many beneficiaries who need help immediately are individuals with ALS whose hospitalizations often increase in frequency as their disease progresses, and who are facing a premature death. Capped rental necessitates that they literally lose their ability to communicate with each hospitalization.

4. There are immediate solutions to the current situation. Several groups have already submitted comments with viable options. For example, allowing individual beneficiaries to pay for upgrades to their SGD from the first day of rental or easing the unworkable rules regarding hospital stays. Consider that hospitals have a bevy of wheelchairs available for use however rarely have any SGDs available to provide a method of communication. Indeed, SGDs provide individualized communication that is often the sole means of access to essential messages for individuals with severe communication impairments. The currently proposed changes to SGD funding increase the vulnerabilities of already extremely vulnerable people.

CMS must take responsibility for the harm it is currently causing to people whose situation is already extremely vulnerable. CMS can no longer pretend that the direct harm being done to people, the reluctance on the part of beneficiaries to replace old and fragile SGDs with the new SGDs they are entitled to and the amazing level of fear and anxiety among people who currently possess devices with upgrades that are wearing out and becoming more difficult to repair does not exist.

Please consider alternate options to this policy.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I support all the above revisions and recommendations as proposed by ASHA.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.
In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.
The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.
Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Medicare (CMS) currently is reconsidering its National Coverage Decision (NCD) for Speech Generating Devices (SGDs). As part of that process, CMS will allow interested members of the public to submit comments about future Medicare SGD coverage until December 6, 2014. The information that follows was prepared by the Medicare Implementation Team, an ad hoc group of AAC clinicians, researchers, advocates, educators, manufacturers, etc., many of whom worked on the 2001 NCD.

FOLLOW THESE 5 SIMPLE STEPS TO SUBMIT A COMMENT TO CMS.

1. Review the 8 PROPOSED COMMENT AREAS below that are critical to include in a revised NCD for SGDs.

2. Copy the Comment Areas so you can PASTE them to the Comment Section on the CMS website. We recommend pasting the 8 comments to a Word Document first so you can add personal information and experiences that strengthen your submission and then paste those into the comment section. (Of course, you may also chose to select fewer of these comments, or only one, if you wish to concentrate your personal comments on a particular point. Also, you can submit several times, each with the focus on one comment, or just a few comments.)

3. Click here to visit the CMS website in a new window. Note: Before you will be allowed to enter any text, you will need to click the link to view the "CMS PHI Posting Policy" and then check the box next to the statement: “I have read and understand the CMS policy regarding redaction of PHI”

4. Fill in the form on the CMS website and PASTE your comments to the "Comment" box. The fields with the red asterisks are mandatory!

5. When you are satisfied with your comments, click the orange SUBMIT button at the lower right corner of the page. Your comments will not be recorded until you click SUBMIT!

DEADLINE FOR COMMENTS IS DEC. 6, 2014

Copy the following into your document and then paste into the Comment box on the CMS site

PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Please continue to support speech-generating devices (SGDs) as a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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